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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 22, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07058155). This is a study registration, not published results. Lead sponsor: The Cleveland Clinic. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Liver Cirrhoses, Portal Hypertension Related to Cirrhosis, Severe Obesity, TIPS. Interventions: PROCEDURE: Transjugular Intrahepatic Portosystemic Shunt (TIPS); PROCEDURE: Sleeve Gastrectomy; DRUG: Anti-Obesity Pharmacotherapy (Class Effect); BEHAVIORAL: Lifestyle Counseling - Diet & Physical-Activity Program. Primary outcome measures: Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months , At 6 months after treatment initiation (Day 0 = TIPS placement date or start of medical management).. Brief summary: Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present. This study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes. The study will compare two groups: 1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG). 2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications). All participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups. The main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment. Participants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes. This study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.